The benefit of IND if previous issues have been resolved, then the IND could be taken off clinical hold and approved within 30 days. Or if the FDA do not respond automatically approved.
The question is whether whether the clinical hold status has been removed?
Aside from that the partnering aspect is relevant. We know that P2 trials in US are a pathway to approval. Therefore Race will need to partner for that P2 trial.
This is not only to foot the bill given the trial in the US are very costly, but more importantly to pass the Batton for Pharma to run the trial as they require to obtain approval.
Whilst I believe Race are chasing partnerships for a Us trial not sure that there is anything imminent. Gut feel only that they will await P2 readouts at a minimum, and ideally EMD readouts before signing a deal - to maximise value and give comfort to Pharma.
Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-50
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